摘要:
目的: 制备尼莫地平固体分散体,增加其溶出速度。 方法: 应用聚乙烯吡咯烷酮(PVP)为载体,采用喷雾干燥制备尼莫地平固体分散体,通过差示扫描量热分析(DSC)和X-射线粉末衍射分析鉴别药物在载体中的存在状态,并进行了体外溶出度研究。 结果: 尼莫地平在载体中以分子状态存在,尼莫地平固体分散体的溶出度与尼莫地平原料药和原料药载体物理混合物相比有显著提高,载体比例越大,药物溶出越快,药物载体比例为1:3时t50仅0.972 6 min。 结论: 聚乙烯吡咯烷酮(PVP)作为尼莫地平固体分散体的载体载药量大;喷雾干燥工艺重现性好,分散体颗粒无需粉碎可满足各类固体制剂的制备要求,是一种较理想的尼莫地平固体分散体的制备方法。
Abstract:
Objective To prepare Nimodipine solid dispersion and increase its dissolution rate.Methonds Using polyvinylpyrrolidone(PVP) as a carrier,nimodipine solid dispersion was prepared by spray-drying method.differential scanning calorimetry and X-Ray powder Diffractometer were used to investigate the status of nimodipine in carriers,and dissolution characteristics were studied in vitro. Results Nimodipine was in the form of molecular in its carrier.The solubility of solid dispersion was significantly increased comparing with that of the pure drug or physical mixtures.Dissolution Results showed that higher carrier-Nimodipine ratio led to faster drug dissolution,t50 of solid dispersions(NimodipinePVP=1:3) is only 0.972 6 min. Conclusion Polyvinylpyrrolidone(PVP) as a carrier of Nimodipine solid dispersion has a high load ability;spray-drying method has good reproducibility;dispersoid particles need not to be smashed and can satisfy request for each kind of solid dosage form.Spray drying technique is a ideal method for the preparation of nimodipine solid dispersion.
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